OctavaColon Cancer Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol

Eventus Diagnostics

Status: Unknown

Conditions: Colon Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02066259

OctavaColon_001

Details and patient eligibility

About

The OctavaColon tests are qualitative plasma tests that are indicated to people above 18 years of age suspected with colon abnormality. The blood tests will provide additional information to the doctor in the course of colon cancer diagnosis for both normal population and high risk population

Full description

The clinical objective of this study is to develop two antibody-based blood tests for additional information during colon cancer diagnosis -

1. Highly specific (OctavaGold) - provides additional information to doctors during evaluation of normal population.
2. Highly sensitive (OctavaSilver) - provides additional information to doctors during evaluation of high risk population.

The study will be considered successful it can achieve at least one of the following sets of performances -

1. For the OctavaGold - 95% specificity with at least 50% sensitivity.
2. For the OctavaSilver - 95% sensitivity with at least 50% specificity. The biological objective of this study is to find the best set of antigens, that when combined with the appropriate algorithm will support each of the above clinical objectives

Enrollment: 1,080 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Subjects 18 years or over. Subjects scheduled for colonoscopy or surgery

Exclusion criteria

• Subjects less than 18 years of age
• Previous or concurrent synchronous cancers other than previous malignancies of the colon and recovered melanoma
• Autoimmune disorders diagnosed subjects
• Hematological malignancies
• Subjects under active chemotherapy treatment or chemotherapy in the past 6 months
• Steroid treatment in the past 3 months
• Subject undergoing immunosuppressive treatments
• Subject with verified melanoma colon cancer
• Subject with verified sarcoma colon cancer

Trial design

1,080 participants in 3 patient groups

healthy_0

Description:

healthy, people with normal (negative) colonoscopy results.

patient_1

Description:

people with biopsy/surgery verified carcinoma of the colon, either an Adenocarcinoma, or carcinoma in situ

benign_2

Description:

people with biopsy verified benign polyps of the colon one of the following - Villus adenoma, Tubular adenoma, Low grade dysplasia, Intermediate grade dysplasia, High grade dysplasia, Severe dysplasia